The Medical Marihuana Act: An Overview

1. The Medical Marihuana Act: An Overview Melanie B. Brim Director Bureau of Health Professions Michigan Department of Community Health

2. Essential Elements of Program • Permits use of marihuana for patients with qualifying medical conditions • Requires DCH to maintain a registry of individuals authorized to use or assist with the use of medical marihuana • Sets limits on the amount of marihuana an individual can possess • Identifies qualifying medical conditions • Requires physician certification of qualifying medical condition

3. What the program does NOT do… • Legalize sales of marihuana to qualified patient or caregiver • Allow certification of qualifying medical condition by a health professional other than a physician • Legalize use outside of Michigan • Require trial of other therapeutic interventions first • Prohibit concurrent use of other prescribed controlled substances • Invalidate Federal Controlled Substances Act

4. Implementation Challenges • Implementing the MMP when the organization: • Opposes smoking • Advocates for prevention and management of chronic disease • Enforces compliance with federal Controlled Substances Act • Marihuana is still illegal under Controlled Substances Act as a Schedule 1 Controlled Substance

5. Implementation Challenges • Regulates health professionals • Oversees the Controlled Substance Advisory Commission • Manages the Health Professional Recovery Program for health professionals with substance abuse and mental health issues. • Manages Drug Control Policy

6. What is permitted? • Acquisition, possession, cultivation, manufacture, use, internal possession, delivery, transfer, or transportation of marihuana or paraphernalia relating to the administration of marihuana to treat or alleviate a registered qualifying patient’s debilitating medical condition or symptoms associated with the debilitating medical condition

7. Cancer Glaucoma HIV AIDS Hepatitis C Amyotrophic lateral sclerosis Crohn’s disease Agitation of Alzheimer’s disease Nail patella Or the treatment of these conditions Treatment of chronic or debilitating disease or medical condition or its treatment that produces 1 or more of the following: Cachexia or wasting syndrome Severe and chronic pain Severe nausea Seizures such as epilepsy Severe or persistent muscle spasms such as multiple sclerosis Qualifying Medical Conditions

8. Role of DCH • Create a registry of individuals who: • Meet the definition of a qualified patient who can use marihuana for medical purposes, or • Are designated as the primary caregiver for a qualified patient • Approve additions to the list of qualifying medical conditions

9. Registration Process • Submits approved application, fee, and physician certification to BHP • New or renewal application $100 • Reduced fee of $25.00 available to individuals currently participating in a Medicaid Health Plan or receiving SSI benefits • Approximately 60% of applicants are paying the reduced fee

10. Registration Process • DCH has 15 days to approve or deny an application and an additional 5 days to issue the card • Applications are reviewed within 15 days of receipt. Incomplete applications are denied and applicants are then notified of denial by certified and regular mail. • The MMA currently allows for a copy of the application submitted to serve as a valid registry identification if the card is not issued within 20 days of its submission to the department.

11. Registration Process • Registration is good for only one year • Must reapply each year by submitting a completed application form, fee and physician certification form

12. Minor Registration Cards A person under 18 can be registered if: • 2 physicians certify medical condition • Parent or guardian consents to allow use • Parent or guardian agrees to serve as primary caregiver • Parent or guardian agrees to control acquisition, dosage and frequency of use

13. Caregiver Requirements • Patient identifies individual as the primary caregiver on the registration application form • The primary caregiver must: • be 21 years old • have no felony convictions involving illegal drugs • agree to assist patient with medical use of marihuana • Note: The caregiver may also be a registered qualified patient

14. Role of the Physician • Participation is voluntary • Primary role is to complete the Physician’s Certification • Patient was evaluated • Patient has 1 or more qualifying medical conditions • Potential for therapeutic or palliative benefit • Physician is NOT prescribing marihuana

15. Impact of Non-Participation • Patient leaves physician’s practice • Patient seeks alternate way to obtain registration card resulting in • Treatment without knowledge • Ineffective/inappropriate treatment regimens • Potential for drug interactions

16. Possession Limits • How much marihuana can a qualifying patient possess? • 2.5 ounces of usable marihuana (excludes seeds, stalks and roots) • 12 marihuana plants kept in an enclosed, locked facility

17. Possession Limits - Caregivers • Caregiver can only possess marihuana if designated to do so by qualifying patient • Limits per patient are: • 2.5 ounces of usable marihuana (excludes seeds, stalks and roots) • 12 marihuana plants kept in an enclosed, locked facility • No more than 5 patients per caregiver

18. How does one “acquire” marihuana? • Act is silent on this issue • State is not authorized to regulate growing sites or quality of product under the Act • State and federal restrictions on selling marihuana

19. Confidentiality • List of qualified patients and approved caregivers holding registry ID cards is confidential • Information can be disclosed to: • Authorized DCH employees as part of their job • Authorized employees of state or local law enforcement agencies, only as necessary to verify that a person legally possesses a registry ID card • At the written request of the patient

20. Issue: Medical Concerns • Lack of clinical research on therapeutic properties • Lack of standardization of ingredients or potency • Limited information on dosing or routes of delivery • Potential drug-disease and drug-drug interactions

21. Issue: Medical Concerns • Limited data to support use of marihuana for most conditions • Note: There is clinical data to support use for: • HIV Wasting - Appetite stimulation • Chemotherapy-induced nausea and vomiting • Potential liability since quantity and quality may be outside physician’s control and there may be adverse cumulative effects

22. Issue: Protection for Physicians • Good faith protection for physicians against medical board or law enforcement action if compliant with intent of the Act • Suggested “Best Practice” • Presence of a medical record • Evidence of an evaluation • Documentation supporting presence of a qualifying medical condition

23. Issue: Physician Licensure Concerns • Possible disciplinary action by a medical board for: • Failure to properly evaluate the patient • Failure to establish a qualifying medical condition • Falsifying a certification • “Certification Mill” • Impact of practicing “under the influence” • Potential for discipline in other states where medical use is not legal

24. Issue: Employment Concerns • Permit/prohibit employment of permit holders? • Obligation to accommodate ingestion in the workplace or working while under the influence? • Obligation to accommodate employees under ADA?

25. Unanswered Questions • Is there a standard of care that a physician could potentially violate? • Who must make the initial diagnosis of a debilitating medical condition? Does the certifying physician need to make the diagnosis?

26. Unanswered questions • A physician is immune from prosecution and discipline if certification is provided in the course of a “bona fide” physician-patient relationship after completing a “full assessment” of the medical history • What constitutes a “bona fide” relationship? • What’s a “full assessment?” • Does there need to be a continuing relationship between the physician and the patient?

27. Unanswered questions • What is a “public place?” • What is a locked enclosed facility? • What does it mean to be in the “presence” or “vicinity” of the medical use of marihuana? • What about exposure to second-hand smoke? • When is someone “under the influence”? • Is there a clear standard?

28. Program Statistics • As of September 10, 2010 • Received 56,513 applications • 29,336 patient cards issued • 32,270 new and renewal cards issued • 13,868 caregiver cards issued • NOTE: This is not reflective of the actual number of individual caregivers registered as this number includes cards issued to a caregiver with multiple patients. A caregiver is issued a separate card for each of the patients under their care. • 7,039 applications denied

29. Program Statistics • Top qualifying medical conditions • Severe nausea • Severe and chronic pain • Severe and persistent muscle spasms • Experiencing increase in the number of physicians completing certifications

30. Additional Information • www.michigan.gov/mmp • Updates on program including statistics • Act and Administrative Rules • Forms for permits and record updates • Frequently Asked Questions • Contact information • Annual Program Report (First report scheduled for late spring 2010)

31. Contact Information • Melanie Brim Director, Bureau of Health Professions (517)-373-8165 Brimm@michigan.gov